Wednesday, March 29, 2006

On "Configuring N.J.'s future in stem-cell research"

There was one "letter to the editor" commenting on my February 23 Trenton Times op-ed on stem cell research.

Double dipping
Monday, March 06, 2006

Former Gov. Dick Codey and his cronies return once again to the public trough to fund embryo-destructive research ("Configuring N.J.'s future in stem-cell research," Feb. 23). They just won't quit.

Why should they? There are more than 500,000 frozen embryos warehoused in fertility clinics, many of which were paid for with mandated public insurance subsidies, such as were imposed by Codey and the New Jersey Legislature.

Spending more money to destroy the embryos is a soullessly efficient way to get bigger bucks than were already taken from the public to pay for embryo creation and to simultaneously reduce this embarrassing, growing glut of stockpiled humans.


Highland Park

In the interest of full disclosure of the issues I raised in the op-ed of February 23, 2006, here is the piece:

Configuring N.J.'s future in stem-cell research

Stem cells, undifferentiated cells that have the ability to turn into specific cell types, hold promise to beneficially affect health problems such as diabetes, Parkinson's and Alzheimer's diseases, stroke, heart attack and spinal cord injury. There are three sources of stem cells, of which one type, cells derived from early-stage human embryos, has caused controversy, because the creation of an embryonic stem-cell ``line'' requires the destruction of a human embryo. Because of this, President George W. Bush in 2001 stated his intention to "allow federal funds to be used for research on existing stem- cell lines, where the life-and-death decision has already been made," but no federal funds would be available for new stem-cell lines. The controversy remains, with recent discussion on CBS' ``60 Minutes'' (Feb. 12), featuring insights from Professor Robert George of Princeton University and Dr. Richard Scott of Morristown.

Because of the limitation on federal funding support for embryonic stem-cell work, various states have entered the arena of stem-cell support. On Nov. 2, 2004, California voters endorsed Proposition 71, a $3 billion initiative for stem-cell research. Within New Jersey, former Gov. Richard Codey advocated an approximately $350 million initiative for stem-cell research. The New Jersey proposal was supported by a Rutgers University study, which recommended that the state should get a one percent royalty on any medical treatments produced by researchers receiving state grants, generating an estimated $21 million. Assuming that new stem-cell therapies start in 10 years, insurers and individuals would save a combined $11.3 billion in health-care costs. Further, a March 2005 poll by the Civil Society Institute of Massachusetts showed that most New Jerseyans supported Codey's plan to finance stem-cell research.

Certain events have occurred since the time of the Rutgers report and Civil Society poll that should be considered by New Jerseyans in deciding the utility of a state-funded stem-cell initiative. Leaving aside the ethical issue associated with embryonic stem cells, one sees that there are other issues that might keep New Jersey taxpayers from getting a reasonable return on the stem- cell investment.

First, one may question whether any income from patent royalties will be received. In California, as in New Jersey, there were promises of a return to the taxpayer through patent royalties. Specifically, Proposition 71 supporters pointed to a Stanford University analysis projecting great patent royalty return. However, a later legal opinion prepared for California State Treasurer Phil Angelides noted that patents and royalties resulting from state grants might be construed as taxable assets, making them ineligible for financing by tax-exempt bonds. IRS rules largely forbid the states to use tax-exempt bonds to benefit specific private enterprises rather than serving a general public good _ and to share revenue from an enterprise to the extent that the state becomes like a business partner. This complication should be evaluated by New Jersey voters who might otherwise expect that tax-free bonds can be used to finance joint ventures wherein the private entity holds the patent right.

Second, one may question whether state funding will produce any FDA-approved stem-cell therapy in 10 years. Patents issued in the next few years may be "too soon" in time, because commercialization of embryonic stem-cell work is a long way off. Further, with the Supreme Court decision in Merck v. Integra, other researchers, including commercial entities, are free to use patents, without payment of royalties, for the purposes of complying with any FDA requirements. New Jersey taxpayers may pave the way for later innovators without seeing return on their investment.
The concern about timeliness has been heightened by the recent discovery of fraud in papers published in Science in 2004 and 2005 by the Korean researcher Woo Suk Hwang. Although the New Jersey studies were completed against a baseline that it was possible to harvest human stem cells from blastocysts generated through somatic cell nuclear transfer (SCNT) (2004 paper) and to generate patient-specific embryonic stem cells (2005 paper), it is now apparent that no one has harvested human SCNT-derived embryonic stem cells or generated patient-specific stem cells. Sadly, the best and brightest minds in the stem- cell field couldn't catch Hwang's fraud and overstated research, which was revealed by anonymous Internet postings by co-workers. Further, readers of the Hwang papers were not apprised of the separate patent positions staked out by co-authors Hwang and Schatten, which suggest that conflicts of interest may permeate the scientific literature of the area.

NOTE: Lawrence B. Ebert is a registered patent attorney admitted in New Jersey and New York. He is the author of ``Lessons to be Learned from the Hwang Matter: Analyzing Innovation the Right Way,'' to be published in the Journal of the Patent and Trademark Office Society in March 2006.

[the bolding has been added]

AFTER the "letter to the editor" and the op-ed, the New Jersey legislature took some votes. The issues contemplated by the legislature were not the ethics issues, the patent issues, or the enablement issues. From the Newark Star-Ledger on March 14, 2006 (bolding added by IPBiz):

Yesterday [March 13, 2006], an Assembly Committee and the full Senate both voted to add a stem cell research facility at the New Jersey Institute of Technology in Newark to the plan.

The Senate version adds $50 million for NJIT to the $200 million already in the bill for a Stem Cell Institute in New Brunswick and a research facility in Camden. But the Assembly version carves out $50 million for the Newark project while keeping the total cost at $200 million. Either way the facilities would be built with money borrowed against future cigarette tax revenues.

Under the Senate bill, sponsored by Senate President Richard Codey, the institute would include:

# The $50 million lab in Newark, where the focus would be on commercial applications and clinical trials of adult stem cells.

# A $150 million facility at Rutgers University in New Brunswick, to be run jointly by the University of Medicine and Dentistry of New Jersey and the Robert Wood Johnson Medical School. It would focus on cutting-edge research on stem cells, including embryonic stem cells.

# A $50 million facility at Rutgers-Camden in collaboration with the Coriell Institute for Medical Research and the Cancer Institute of New Jersey, focused on stem cells from cord blood, placentas and other human tissue.

The Ledger included the text: "This is an exciting time for the scientific, research and academic communities to be joining together," Sen. Wayne Bryant (D-Camden) said. "Very good things will happen by attracting the greatest research minds in the nation."

The Ledger article also stated:

Assemblyman Neil Cohen (D-Union) said that Assembly version might require scaling back the facility in New Brunswick, where plans are already finalized and construction could begin as early as this summer.

However, he argued that it was "extras," not the basic facility, that would be lost. "That place can be built for $100 million," Cohen said.

Sponsors in both chambers expect to work out differences in the two bills before the Senate vote next week.

Assembly Speaker Joe Roberts has no objection to creating three facilities but has concerns about the total amount of money allocated, according to Assembly Democratic spokesman Joseph Donnelly.

Still to come is money for actual research at the new facilities.

Codey has also introduced a bill that seeks voter approval, possibly as soon as the November election, to borrow $230 million more to award grants to researchers at the new facilities.

[IPBiz note: The amount of money involved is $480 million ($250 million for the facilities and $230 million for money to do research in the facilities). The March 14 article was written by DEBORAH HOWLETT, available at]


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